Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Grecia, Costa Rica

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Quality Engineer.

Purpose:

Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, MDSAP and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems but independently determines and develops approaches and solutions. Share technical expertise and collaborate with R&D, Engineering/Technical Operations, Quality, Operations, business and partners/stakeholders to implement processes, systems, and procedures.

You will be responsible for

In accordance with all applicable federal, state, and local laws/regulations and Johnson & Johnson corporate procedures and guidelines, this position:

• Utilize Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts related to quality improvement opportunities, and/or customer satisfaction.
• Develop and establish effective quality control and support associated risk management plans.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications and engineering change orders including IQ, OQ, PQ, Process Verifications and Test Method Validation (TMV).
• Ensure that all critical to quality (CTQ) features are identified and adequately addressed in control plan by qualified test methods.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
• Lead risk management activities using process FMEAs to ensure that process risk has been fully assessed, appropriate risk controls implemented, and risk reduced as far as possible.
• Execute sampling plans and/or applicable testing prior to releasing raw materials.
• Support vendor audits as technical lead as needed and support Supplier Quality as Quality representative as appropriate.
• Conduct investigation, bounding, documentation, review and approval of non-conformances.
• Initiate and investigate Corrective and Preventative Actions (CAPA).
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Assist in complaint analysis as appropriate.
• Follows formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
• Complies with all applicable quality, environmental, occupational health and safety management system policies. (e.g., ISO 13485, ISO14001, and OSHAS18001).

Others:

• Responsible for communicating business-related issues or opportunities to the next level of management.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all federal, state, local, local, and Company regulations, policies, and procedures.
• Performs other assigned duties as necessary.

Qualifications / Requirements:

Experience and education

• A minimum of a university bachelor’s degree, preferably in engineering: Mechanical, Electrical, Chemical, Industrial or applicable science.
• 0 – 2 years of experience as a quality, manufacturing or research and development professional in the Medical Device Industry.

Required knowledge, skills, abilities, certifications/licenses and affiliations

• Practical knowledge of regulatory requirements is required (21 CFR Part 820, MDD, ISO 9001, ISO 13485, ISO 14971, or other international standards).
• Ability to develop and implement Quality standards.
• Thorough knowledge of Quality, operations systems and processes, including GMP and QSR requirements for medical devices
• Thorough knowledge of problem-solving methodologies.
• Knowledge of specific business practices and proficiency in software applications (Word, Excel, PowerPoint, Minitab, Visio, Microsoft Project).
• Ability to collaborate with all levels of management in a cross-functional team environment.
• Effective communication skills in English are required.

Preferred:

• Understanding of Six Sigma and Business Excellence tools and methodologies. Lean manufacturing experience is desirable.
• Strong analytical skills, metric development, and trend identification capabilities are desirable.
• Experience working with ERP systems and associated Quality process flows.

#LI-Onsite

Required Skills:

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy